Sr Spec Clinical Product Surveillance

Medline Industries, LP; Mundelein (IL); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Clinical Product Surveillance professional to lead post-market investigations, evaluate complaints, and coordinate MDR submissions with FDA and international authorities. You will mentor the Clinical Product Surveillance team and provide clinical expertise to QA and product divisions.

The role requires a Bachelor's degree in medical sciences or healthcare field and at least 6 years of clinical or risk management experience, with strong data analysis and

Qualifications

• Bachelor's degree in medical science or related field and at least 4 years of clinical, medical device risk management, or pharmaceutical risk management experience OR Healthcare provider certificate/licensure.
• Experience documenting and reporting safety data for regulatory programs.
• Ability to communicate technical information to non-technical audiences.

Responsibilities

• Identify and evaluate complaints affecting patient safety.
• Prepare and submit MDRs and adverse event reports to FDA.
• Coordinate international report filing with health authorities.
• Lead risk analyses and develop product risk controls.
• Provide clinical support to QA, sales, and product teams.

Skills

Data analysis

Technical communication

Cross-functional teamwork

Project management

Time management

Microsoft Office

Education

Bachelor's degree in medical science/health sciences or healthcare related field

Healthcare provider certificate/licensure

Tools

Microsoft Office

Job description

Job Summary

Under minimal supervision, use knowledge of clinical workflow and product use in assessing incoming complaints and hazards. Assist in post-market reportability determination.
Leads clinical investigations for reported product incidents and submit adverse event reports.
Provides clinical resource support to customers, sales reps and the product division for clinical issues. Identify hazardous situations from product design, product/material assessments, and customer complaints.
Responsible for mentoring and coaching the Clinical Product Surveillance team.

Job Description

MAJOR RESPONSIBILITIES:

• Identify and evaluate complaints which affect patient safety.
• Prepare and submit Medical Device Reports (MDRs) and drug adverse event reports to the FDA.
• Process MDRs and coordinate international report filing with local health authorities.
• Ensure reportable complaints are processed and submitted. Collaborate with team members; act as a clinical resource to QA and product division.
• Review, evaluate and classify potential reportable customer safety complaints.
• Ensure customer communications are created and issued; review customer responses for technical accuracy related to Medline products.
• Conduct risk analysis and design development modifications for new and existing products; provide clinical insight, review, and risk controls leads. Assist in CERs for EU/CE marked devices.
• Lead the patient safety and risk analysis. Ensure compliance with applicable post-market regulations.
• Identify product safety issues; triage complaints for further investigation.
• Develop and maintain procedures for MDR/ Adverse Event Reporting for medical device, drug, FDA regulated products and international products.
• Perform, review, and write HHE product recall assessments.
• Conduct trainings related to Post-market surveillance, clinical use, product risk, and SOP requirements.
• Compose and submit AI response letters to FDA.
• Lead team projects and assignments; provides peer mentoring and expertise for new team members.

MINIMUM JOB REQUIREMENTS:

Education:

• Bachelor's degree in medical science, health sciences or healthcare related field and at least 4 years of clinical, medical device risk management, or pharmaceutical risk management experience OR Healthcare provider certificate/licensure.

Certification / Licensure:

• None

Work Experience:

• at least 6 years of clinical, medical device risk management, or pharmaceutical risk management experience.

Knowledge / Skills / Abilities:

• Experience with analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Experience communicating technical information to non-technical audiences.
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems.
• Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.
• Experience with Microsoft Office.

PREFERRED JOB REQUIREMENTS:

Education:

• Bachelor's Degree in Nursing.

Certification / Licensure:

• Licensed, registered, or certified by a state or other governing body to administer health care.

Work Experience:

• Experience applying knowledge of FDA and international Health Authority reporting requirements.

Knowledge / Skills / Abilities:

• Understanding of the clinical environment and product work flow.
• Familiarity with the application of medical device as it relates to patient safety.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$92,000.00 - $138,000.00 Annual

The actual salary will vary based on applicants' location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click [here](https://urldefense.com/v3/ https:/digital.alight.com/medline ;!!DjNdo6avjEs!o-bxZ6fy_WNH13q2FLYYmUMb1U4cic3ioox3ulm5dkpyivWM09cd64RN8rHuDH5AQKNiwEzHU2VbVJht5ginULSy5aJGsA$).

We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.